DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1

K973873 · American Telecare, Inc. · DRG · Dec 29, 1997 · Cardiovascular

Device Facts

• Record ID: K973873
• Device Name: DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
• Applicant: American Telecare, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Dec 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

The Digital Personal Telemedicine Module is intended to be used solely as a monitoring device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds.

Device Story

Digital Personal Telemedicine Module (Digital PTM) functions as a monitoring kit; houses blood pressure meter, telephonic stethoscope, and speaker/microphone circuit in a single enclosure. Components are not interconnected by hardware or software. Used by patients at home to facilitate remote communication with healthcare professionals. Operation involves connecting to a video system, establishing voice/video links, and transmitting auscultatory sounds (heart/lung) and vital signs (BP/pulse) to a remote receiving unit. The device utilizes the CareTone II/LBR stethoscope, which converts analog auscultatory signals to digital binary signals for transmission. Healthcare providers use the received audio and data to monitor patient status between visits. Benefits include improved access to patient physiological data without requiring in-person clinical visits.

Clinical Evidence

Bench testing and clinical studies were conducted to evaluate the performance of the CareTone II/LBR stethoscope compared to the CareTone II. Results demonstrated that the digital encoding modification did not adversely affect the quality of the transmitted auscultatory signal.

Technological Characteristics

Kit containing blood pressure meter, telephonic stethoscope (CareTone II/LBR), and speaker/microphone circuit in a common housing. No hardware or software interconnection between components. Stethoscope uses digital binary signal encoding for auscultatory sounds. Standalone monitoring system.

Indications for Use

Indicated for patients requiring remote monitoring of blood pressure, pulse, and heart/lung sounds by a healthcare professional between clinical visits. Not for diagnostic purposes.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• American TeleCare's Personal Telemedicine Module (K964554)
• American TeleCare's CareTone II Telephonic Stethoscope (K963678)

Submission Summary (Full Text)

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K973873

1

# 510K SUMMARY

# American TeleCare's Digital Personal Telemedicine Module

DEC 2 9 1997

## Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared

American TeleCare, Inc. 7640 Golden Triangle Drive Eden Prairie, MN 55344-3732

Contact Person:

C. Richard Abbruscato American TeleCare, Inc. Telephone: [phone] Facsimile: [phone]

Date Prepared: October 9, 1997

## Name of Device

Digital Personal Telemedicine Module

#### Common or Usual Name

Telemedicine Communications Module

## Classification Name

Powered Communication System

#### Predicate Devices

- 1. American TeleCare's Personal Telemedicine Module (K964554); and
- 2. American TeleCare's CareTone II Telephonic Stethoscope (K963678)

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### Substantial Equivalence

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The Digital Telemedicine Module ("Digital PTM") and the predicate devices listed above have the same intended use and principles of operation and very similar technological characteristics. Specifically, both the Digital PTM and the Personal Telemedicine Module ("PTM") consist primarily of a blood pressure meter, a telephonic stethoscope, and a speaker/microphone circuit; these three components are placed in a common housing but are not interconnected by hardware or software. Both devices are intended for use as monitoring devices, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds. Neither device is intended to be used for diagnostic purposes. In general, operation of either device consists of: 1) connecting the device to a video system; 2) establishing voice/video communication; 3) establishing communication between the sending and receiving units of a telephonic stethoscope; 4) obtaining a blood pressure and pulse reading; and 5} obtaining and transmitting to heart or lung sounds.

The only difference between the two devices is that the PTM contains American TeleCare's CareTone Telephonic Stethoscope ("CareTone"), while the Digital PTM contains American TeleCare's CareTone II/LBR Telephonic Stethoscope ("CareTone II/LBR"). the second generation model of American TeleCare's CareTone II Telephonic This minor modification to the technological Stethoscope ("CareTone II"). characteristics of the Digital PTM does not raise new questions of safety or effectiveness, because 1) the Digital PTM is a kit that provides the telephonic stethoscope in a common enclosure with the blood pressure monitor and the microphone/speaker circuit for the convenience of the patient: 2) the telephonic stethoscope is not interconnected with the other components of the Digital PTM; and 3.) the modifications made to the CareTone II/LBR, when compared with the CareTone II's characteristics, do not raise new questions or effectiveness regarding the stethoscope. Thus, the Digital PTM is substantially equivalent to the predicate devices.

With regard to the telephonic stethoscopes, the primary differences between the CareTone II and the CareTone II/LBR are: 1) the method used to encode the auscultatory sounds from the analog signal to a digital binary signal; 2) the process by which data are received at the receiving end unit of the telephonic stethoscope. These technological differences do not raise new questions of safety or effectiveness; bench testing and clinical studies demonstrate that these modifications do not adversely affect the quality of the transmitted signal.

Thus, the CareTone II/LBR is substantially equivalent to the CareTone II; therefore, as described above, the Digital PTM is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

# DEC 2 9 1997

Mr. C. Richard Abbruscato Vice President, Engineering and Manufacturing Operations American TeleCare, Inc. 7640 Golden Triangle Drive Eden Prairie, MN 55344

Re: K973873 Digital Personal Telemedicine Module Trade Name: Requlatory Class: II (two) Product Code: 74 DRG Dated: October 9, 1997 October 10, 1997 Received:

Dear Mr. Abbruscato:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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#### Page 2 - Mr. C. Richard Abbruscato

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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:10(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Digital Personal Telemedicine Module )evice Name:_

ndications For Use:

..

scription Use

7 21 CFR 801.109)

The Digital Personal Telemedicine Module is intended to be used solely as a monitoring device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung · sounds .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (C

V. Oanh Tiller

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number

Over-The-Counter/Use

(Optional Formal 1-2-96)

OR